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临床试验/NCT00629005
NCT00629005已完成1 期

Should We Train Strength or Skill in Post-Stroke Rehabilitation?

US Department of Veterans Affairs2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Fugl-Meyer Motor Assessment - UE Subscale

研究概览

简要总结

People with stroke experience weakness and incoordination. Studies have shown that with functional task practice, people can increase motor control and strength to a certain extent. This study will investigate whether adding progressive resistance strength training to functional task practice modeled after Constraint-Induced Movement Therapy results in greater motor function gains than functional task practice alone

详细描述

To date most investigations of UE rehabilitation have examined single interventions. However, combining 2 efficacious interventions may enhance effectiveness. Both functional task training and strength training are beneficial for promoting improved upper extremity function, but they have seldom been studied as a coupled therapy. The research proposed in this project will examine the effect on UE function of adding UE resistive exercises to functional task training. Secondary aims are to examine the effect of stroke severity on the response to therapy, the interrelationship between therapy-induced neural changes and movement composition and functional changes with therapy, and test for retention of UE function gains over 6 months. Individuals with chronic hemiparesis from stroke will complete baseline testing and then be randomly assigned to either the functional task + strength training group or the functional task training alone group. Each group will train 4 hours/day, 3 days/week for 4 weeks. Each will perform 3 hours of functional task training per session. The strengthening group will then complete 1 hour of UE progressive resistance exercises while the functional task training alone group will complete gravity eliminated range of motion exercises for 1 hour. All subjects will be post-tested and then complete follow-up testing 6 months later.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a single unilateral middle cerebral artery ischemic stroke;
  • no history of drug/alcohol abuse;
  • ability to follow 3-step commands and provide informed consent;
  • no history of other neural disorder/dysfunction (including epilepsy), no serious medical illness or refractory depression;
  • at least 300 active upper extremity elevation in scapular plane (combination of flexion and abduction);
  • ability to extend the wrist 20 degrees, and two fingers and thumb 10 degrees three times in a minute;
  • permission of physician (BRRC medical director or BRRC neurologist) to participate in strength training.

排除标准

  • spasticity in elbow or hand (Modified Ashworth Scale > 2);
  • Motor Activity Log32 scores >3 (which would indicate relatively good use of the upper extremity);
  • ability to complete 135 degrees shoulder elevation easily with elbow straight (e.g., doesn't hold breath, movement is fluid, little to no effort tremor observed);
  • ataxia, major sensory deficits, or hemi-inattention/neglect;

结局指标

主要结局

Fugl-Meyer Motor Assessment - UE Subscale

时间窗: Immediately after the end of therapy and 6 months later

次要结局

  • Wolf Motor Function Test(Immediately after the end of therapy and 6 months later)
  • Cortical mapping using transcranial magnetic stimulation(Immediately after the end of therapy)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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